Women's Health, Pregnancy, and the U.S. Food and Drug Administration

The U.S. Food and Drug Administration (FDA) was the first comprehensive consumer protection agency in the United States. The FDA's regulatory functions began with the passage of the 1906 Pure Food and Drugs Act, a law prohibiting interstate commerce in adulterated or misbranded food and drugs. Since that time, there has been an explosion of scientific progress around drugs, devices, and biologics such as vaccines and, concomitantly, the need for safety assurance and consumer protection has grown. This article covers some of the pertinent history of FDA regulation of medications and devices important to women's health care, discusses some of the challenges to progress, and advances some proposals for improved safety and efficacy of drugs in pregnant women. As a result of the dearth of studies of drugs in pregnant women, advancing research for this population of patients is especially critical.